Lyumjev (insulin lispro-aabc injection) / Eli Lilly - LARVOL DELTA

Impact of Ultra-Rapid Insulin on Boost and Ease-Off in the Cambridge Hybrid Closed-Loop System for Individuals With Type 1 Diabetes. (PubMed, J Diabetes Sci Technol) - "There were no safety issues when using Boost and Ease-off with ultra-rapid insulins. The use of Fiasp and Lyumjev during Boost or Ease-off resulted in comparable safety and efficacy to using insulin aspart and lispro."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

TLV-0332-24: Mealtime or Post-meal Dosing of URLi in Medtronic 780G Hybrid Closed Loop System (clinicaltrials.gov) - P4 | N=50 | Not yet recruiting | Sponsor: Tel-Aviv Sourasky Medical Center

New P4 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India (clinicaltrials.gov) - P4 | N=112 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Jul 2025 ➔ Oct 2025 | Trial primary completion date: Jul 2025 ➔ Oct 2025

Trial completion date • Trial primary completion date • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Glycemic Outcomes with Rapid Insulin vs. Ultrarapid Insulin in Omnipod 5 (OP5) (ADA 2024) - "Ultrarapid insulins (Lyumjev, Fiasp) are designed to reduce post-prandial excursions and may be beneficial in automated pumps. However, satisfaction and bolus overrides improved with ultrarapid insulin. A larger sample size and meal-specific measures are needed to connect patient experience with glycemic outcomes."

Diabetes • Metabolic Disorders

A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India (clinicaltrials.gov) - P4 | N=112 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Multicenter Evaluation of Ultra-Rapid Lispro (URLi) Insulin with Control-IQ Technology in Adults, Adolescents and Children with Type 1 Diabetes. (PubMed, Diabetes Technol Ther) - "URLi use in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 technology was safe for adult and pediatric participants with type 1 diabetes, with quality of life benefits of URLi use perceived by the study participants."

Journal • Diabetes • Metabolic Disorders • Pediatrics • Severe Hypoglycemia • Type 1 Diabetes Mellitus

A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India (clinicaltrials.gov) - P4 | N=112 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P4 trial • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Lilly-MEALS: A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre | Trial completion date: Jun 2024 ➔ Dec 2024 | Trial primary completion date: Jun 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

FROM CLINICAL DATA TO CLINICAL INSIGHTS – TRANSFORMATIVE OPPORTUNITIES FOR CLINICAL CARE USING THE LILLY TEMPO PERSONALIZED DIABETES MANAGEMENT PLATFORM: A CLINICAL TUTORIAL (ATTD 2024) - "The Lilly Tempo Smart Button™ enables Basaglar ®, Humalog®, and Lyumjev® insulin dose-related data to automatically transfer to a compatible App. The Tempo system can provide the missing information to the HCPs to transform the guess work and difficult conversations with PwDs to an opportunity for personalized and precision medical advice and better experience to the PwDs and the HCPs."

Clinical data • Diabetes • Metabolic Disorders

EXERCISE INCREASES CIRCULATING INSULIN LISPRO CONCENTRATIONS IN ADULTS WITH TYPE 1 DIABETES ON PUMP THERAPY THAT IS ATTENUATED BY SWITCHING TO ULTRA-RAPID INSULIN LISPRO (URLI) (ATTD 2024) - "The efficacy of performing a 50% BRR 1-hr before exercise with Lispro in CSIIOL is limited by an activity-associated increase in insulin absorption rate that is partially overcome with URLi."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

SAFETY AND PERFORMANCE OF AN ADVANCED HYBRID CLOSED‐LOOP ALGORITHM WITH ULTRA RAPID LISPRO AND LISPRO (ATTD 2024) - "Results suggest reduced hypoglycaemia with URLi vs Lispro with comparable glycaemic control. The AHCL algorithm showed promising glycaemic performance in a supervised setting when used with URLi or Lispro."

Clinical • Metastases • Severe Hypoglycemia

EFFECTS OF MICRO-DOSE GLUCAGON ON SUBCUTANEOUS INSULIN ABSORPTION IN PIGS (ATTD 2024) - "Adding glucagon to Lyumjev® further enhances insulin absorption and the insulin effect on glucose metabolism. This increased insulin absorption may make a fully automated artificial pancreas possible. Further experiments on premixing glucagon and insulin and repeating glucagon injections are ongoing and will also be presented."

Anesthesia

HIGH SATISFACTION WITH CONTROL-IQ 1.5 AND LYUMJEV INSULIN IN CHILDREN, ADOLESCENTS AND ADULTS WITH TYPE 1 DIABETES (ATTD 2024) - "Lyumjev in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 was safe with high treatment satisfaction compared to Humalog for adults and youth with T1D."

Clinical • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Postprandial Glucose Excursions with Ultra-Rapid Insulin Analogues in Hybrid Closed-Loop Therapy for Adults with Type 1 Diabetes. (PubMed, Diabetes Technol Ther) - P=N/A | "In contrast, there were no significant differences in iAUC-2h, iAUC-4h, and the other measures of postprandial glucose control between insulin aspart and Fiasp during breakfast, lunch, and evening meal (p>0.05). Conclusion The use of Lyumjev with CamAPS FX closed-loop system improved postprandial glucose excursions compared with insulin lispro, while the use of Fiasp did not provide any advantage compared with insulin aspart."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adults and Pediatrics Utilizing Lyumjev® (clinicaltrials.gov) - P=N/A | N=244 | Completed | Sponsor: Medtronic Diabetes | Recruiting ➔ Completed

Metastases • Trial completion • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus

Lilly-MEALS: A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

CamAPS FX hybrid closed-loop with ultra-rapid lispro compared with standard lispro in adults with type 1 diabetes: a double-blind, randomized, crossover study. (PubMed, Diabetes Technol Ther) - P=N/A | "The use of ultra-rapid lispro with CamAPS FX hybrid closed-loop increases time in range and reduces mean glucose with no difference in hypoglycemia compared with standard insulin lispro in adults with type 1 diabetes."

Journal • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Fasting and postprandial plasma glucose contributions to hemoglobin A1c and time in range in people with diabetes on multiple daily injection insulin therapy: Results from the PRONTO-T1D and PRONTO-T2D clinical trials. (PubMed, J Diabetes Complications) - P3 | "FPG and PPG significantly impact HbA1c and TIR. Balanced management of both FPG and PPG is important to achieve glycemic goals for people with diabetes on MDI insulin therapy."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Automated Fully Closed-Loop Insulin Delivery in Type 1 Diabetes With Ultra-Rapid Lispro (ACOLYTE Study) (clinicaltrials.gov) - P=N/A | N=26 | Recruiting | Sponsor: Manchester University NHS Foundation Trust | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Ultra-rapid lispro improved postprandial glucose control compared to insulin lispro in predominantly Chinese patients with type 1 diabetes: A prospective, randomized, double-blind phase 3 study. (PubMed, Diabetes Obes Metab) - "In this study, URLi administered in a basal-bolus regimen demonstrated superiority to insulin lispro in controlling PPG excursions, with noninferiority of HbA1c control in predominantly Chinese patients with T1D."

Clinical • Journal • P3 data • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Ultra rapid lispro (Lyumjev®) shortens time to recovery from hyperglycaemia compared to Humalog® in individuals with type 1 diabetes on continuous subcutaneous insulin infusion. (PubMed, Diabetes Obes Metab) - "During episodes of hyperglycaemia commonly experienced in people with type 1 diabetes, URLi provided a faster recovery versus Humalog from a missed mealtime bolus or during basal insulin suspension. URLi shows significant acceleration of insulin absorption versus Humalog when boluses are administered by subcutaneous infusion or injection."

Clinical • Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Assessing Time in Range with Postprandial Glucose-Focused Titration of Ultra Rapid Lispro (URLi) in People with Type 1 Diabetes. (PubMed, Diabetes Ther) - P2 | "URLi in a basal-bolus regimen focusing on PPG targets demonstrated improved overall glycemic control and reduced PPG excursions without increased hypoglycemia in participants with T1D."

Journal • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Safety and performance of an advanced hybrid closed-loop algorithm with ultra rapid lispro and lispro (EASD 2023) - "Results suggest reduced hypoglycaemia with URLi vs Lispro with comparable glycaemic control. The AHCL algorithm showed promising glycaemic performance in a supervised setting when used with URLi or Lispro."

Clinical • Metastases • Metabolic Disorders • Severe Hypoglycemia

Ultra-rapid lispro is more protective against exercise-associated hypoglycaemia over lispro in adults with type 1 diabetes on continuous subcutaneous insulin infusion (EASD 2023) - P1 | "URLi demonstrated an attenuation of exercise-induced glucose lowering compared to Lispro during aerobic exercise using either a 50% or 100% BRR approach. These data suggest that URLi may protect against exercise-associated hypoglycaemia in adults with TID on standard CSII therapy."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

Lilly-MEALS: A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes (clinicaltrials.gov) - P2 | N=12 | Not yet recruiting | Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

New P2 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus